Trial Radar AI | ||
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Clinical Trial NCT07221149 for Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204) Phase 2, Phase 3 690
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
- CA266-0004
- 2025-523263-37 (Other Identifier) (EU CTR)
- U1111-1325-8116 (Other Identifier) (WHO)
Phase 3
Gastroesophageal Junction Cancer
Esophageal Adenocarcinoma
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm A1 | Pumitamig Specified dose on specified days Folfox Specified dose on specified days |
ExperimentalArm A2 | Pumitamig Specified dose on specified days Folfox Specified dose on specified days |
ExperimentalArm B | Folfox Specified dose on specified days Nivolumab Specified dose on specified days |
ExperimentalArm C | Pumitamig Specified dose on specified days Folfox Specified dose on specified days Capox Specified dose on specified days |
ExperimentalArm D | Folfox Specified dose on specified days Capox Specified dose on specified days Nivolumab Specified dose on specified days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment | Phase 2 | Up to 2 years after the last participant is randomized |
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) | Phase 3 | Up to approximately 33 months |
Overall survival (OS) | Phase 3 | Up to approximately 47 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
PFS by RECIST v1.1 per investigator assessment | Phase 2 | Up to approximately 33 months |
Duration of Response (DOR) (CR or PR) by RECIST v1.1 per investigator assessment | Phase 2 | Up to approximately 33 months |
Time to Response (TTR) (CR or PR) by RECIST v1.1 per investigator assessment | Phase 2 | Up to approximately 33 months |
Disease control (Best Overall Response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD)) by RECIST v1.1 per investigator assessment | Phase 2 | Up to approximately 33 months |
Recommended dose of Pumitamig for Phase 3 | Phase 2 | Up to approximately 33 months |
Objective response (OR) by RECIST v1.1 per BICR | Phase 3 | Up to approximately 33 months |
DOR by RECIST v1.1 per BICR | Phase 3 | Up to approximately 33 months |
- Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
- Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1.
- Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
- Participants must have measurable disease as defined by RECIST v1.1.
- Participants must not have untreated known central nervous system (CNS) metastases.
- Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- Participants must not have evidence of major coagulation disorders (eg, hemophilia).
- Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a prophylactic dose.
- Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.
- Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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